Medical device Adverse Signal Detection and Event Reporting (ASDER) Checklist

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1. Data Specifications

Mandatory fields
2.	HEALTHCARE_FACILITY_IDENTIFIER	These mandatory fields represent the minimum information required for an Adverse Event to be reported. If the information contained in these fields does not align to the data domain (format, character limits etc) the report will be rejected, and the report will need to be amended before submitting again.
3.	DATE_OF_USE
4.	INCIDENT_DESCRIPTION
5.	DEVICE_DESCRIPTION
6.	MANUFACTURER

Conditional fields
7.	DATE_OF_DEATH	These conditional fields are required to be reported if the event meets certain conditions. The regulations to report these fields are available here.
8.	DATE_OF_DETERIORATION
9.	DATE_OF_INTERVENTION
10.	DATE_OF_TREATMENT

Optional fields
11.	FACILITY_REPORT_ID	These optional fields are not required to be reported against the regulations for mandatory reporting of adverse events. However, their inclusion in any report to the TGA will help with further analysis of mandatory reporting data.
12.	TREATMENT_DESCRIPTION
13.	UNIQUE_DEVICE_IDENTIFIER
14.	LEVEL_OF_HARM
15.	AGE_GROUP
16.	BATCH_NUMBER
17.	INCIDENT_REFERENCE_ID

2. Please provide facility or organisation name

Facility or organisation name (Required)

3. In which state or territory is your facility or organisation located?

Location

4. Confirm if you have reviewed the data specifications as required part of the new Mandatory reporting legislation?

(Required) Yes No

If No, please provide a date when this will be verified

5. Do you have the ability to extract and map the data specifications from your internal reporting systems?

(Required) Yes No

Please select which data specifications you can extract or map:

HEALTHCARE_FACILITY_IDENTIFIER DATE_OF_USE INCIDENT_DESCRIPTION DEVICE_DESCRIPTION MANUFACTURER DATE_OF_DEATH DATE_OF_DETERIORATION DATE_OF_INTERVENTION DATE_OF_TREATMENT FACILITY_REPORT_ID TREATMENT_DESCRIPTION UNIQUE_DEVICE_IDENTIFIER LEVEL_OF_HARM AGE_GROUP BATCH_NUMBER INCIDENT_REFERENCE_ID

6. Please inform which of the listed data specifications in the tables you cannot provide as part of the mandatory reporting legislation?

Mandatory fields

These mandatory fields represent the minimum information required for an Adverse Event to be reported. If the information contained in these fields does not align to the data domain (format, character limits etc) the report will be rejected, and the report will need to be amended before submitting again.

(Required) HEALTHCARE_FACILITY_IDENTIFIER DATE_OF_USE INCIDENT_DESCRIPTION DEVICE_DESCRIPTION MANUFACTURER Can provide all of the above

Conditional fields

These conditional fields are required to be reported if the event meets certain conditions. The regulations to report these fields are available here.

DATE_OF_DEATH DATE_OF_DETERIORATION DATE_OF_INTERVENTION DATE_OF_TREATMENT Can provide all of the above

Optional fields

These optional fields are not required to be reported against the regulations for mandatory reporting of adverse events. However, their inclusion in any report to the TGA will help with further analysis of mandatory reporting data.

FACILITY_REPORT_ID TREATMENT_DESCRIPTION UNIQUE_DEVICE_IDENTIFIER LEVEL_OF_HARM AGE_GROUP BATCH_NUMBER INCIDENT_REFERENCE_ID

7. Have you contacted the TGA regarding concerns or gaps in your ability to report? Selecting 'no' means there are no issues to submit data through this mechanism

(Required) Yes No

If Yes, please elaborate on the issue raised

8. If you would like your initial data extract to be reviewed before submission, please upload it here.

(Required) Yes No

If Yes, please attach your data extract template

Please make sure your file is under 25MB

9. Have you verified with your technical team any potential issues (e.g. cybersecurity, firewalls etc. ) with the access of external SharePoint websites?

Yes No

Any further information

10. Please specify the user(s) who should be granted access to the ASDER system and fill in the details below.

If you do not have an individual user account, please enter your facility name or team name in the 'Full Name' field, and use your group email address as the contact email.

Contact Full name (Required)

Facility Name (Required)

Position Title

Email Address (Required)

Phone Number

To submit more than one user, please complete and send the form below.

User details form

Submit file

Please make sure your file is under 25MB

11. Please outline any feedback or concerns you may have with the data or reporting scheme.

Fill in the below

Medical device Adverse Signal Detection and Event Reporting (ASDER) Checklist

Criteria: